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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTHORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC LABORATORIES CORP.
PMA NumberP870072
Supplement NumberS006
Date Received12/22/1997
Decision Date01/21/1998
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number N
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) changing the thread sealant/thread locking material for the stinless steel pneumatic driveline fitting to the polysulfone vad case cap from room temperature vulcanizing (rtv) silicone to master bond polymer system ep21lv, and 2) replacing the current two-piece welded hand pump bulb witha single-piece molded bulb.
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